Practice Test Geeks(CLE) Certified Lactation Educator Practice Test
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Good Clinical Practice & ICH Guidelines Flashcards

7 cards from real CLE practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

Read the first 7 Good Clinical Practice & ICH Guidelines flashcards as text

  1. Under ICH E6(R2) GCP, which element is REQUIRED in an informed consent document for a lactation research study?

    Answer: A statement that participation is voluntary and refusal will not affect care

    ICH E6(R2) mandates that informed consent must include a statement that participation is voluntary and that declining or withdrawing will not penalize care.

  2. According to GCP principles, an Institutional Review Board (IRB) must review a breastfeeding study protocol primarily to ensure:

    Answer: The rights, safety, and well-being of human subjects are protected

    The primary mandate of an IRB under GCP is to protect the rights, safety, and well-being of human research subjects.

  3. A lactation educator conducting a clinical study must obtain a new or updated informed consent when:

    Answer: New information becomes available that may affect willingness to continue participation

    GCP requires re-consent whenever new information emerges that could materially affect a subject's willingness to remain in a study.

  4. In GCP-compliant lactation research, the term 'protocol deviation' refers to:

    Answer: Any departure from the approved study protocol that was not pre-authorized

    A protocol deviation is an unplanned, non-pre-authorized departure from the approved study protocol procedures.

  5. Which ICH guideline specifically addresses the conduct of Good Clinical Practice for human clinical trials?

    Answer: ICH E6(R2)

    ICH E6(R2) is the GCP guideline that governs the design, conduct, recording, and reporting of clinical trials involving humans.

  6. Under GCP, source documents in a lactation clinical study serve to:

    Answer: Provide original records from which study data are derived and verified

    Source documents are the original records (e.g., medical charts, lab reports) that allow verification and reconstruction of study data.

  7. A lactation researcher identifies a serious adverse event (SAE) in her study. According to GCP, she must report it to the IRB and sponsor:

    Answer: Promptly, within the timeframe specified in the protocol and applicable regulations

    GCP requires prompt SAE reporting to the IRB and sponsor within the protocol-specified and regulatory timeframes, regardless of causality certainty.